ABOUT – KeyMedic

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About KeyMedic

THE KEY TO SUCCESSFUL REGISTRATION

Why KeyMedic?

Getting your medical device into the market, in a world of ever-changing regulatory requirements, may seem like a long, difficult path.

KeyMedic is a regulatory consulting service provider, established by Yael Spielmann.

At KeyMedic we partner with you to provide the Regulatory, Quality and Compliance keys to markets worldwide, all under one roof. We can guide you throughout your product’s lifecycle, from early stages of development to post market regulatory compliance.

We are focused on learning all about your product and understanding your organization and needs, to obtain the best results.

Yael Spielmann CEO & Founder

Vision

We believe that each company and each product are unique.

KeyMedic is built to discover the most suitable strategies to address regulatory and compliance challenges across the product lifecycle, taking into consideration our clients’ needs and capabilities.

With our knowledge, industry experience and creative approach, we can tailor flexible solutions that will facilitate product licensing worldwide.

We are committed to excellence and on-time delivery.

Expertise

We partner with companies in the medical device industry to provide optimized regulatory and quality solutions.

Products:

Class I, II, IIa, IIb, III and IV medical devices
Vast experience with respiratory, cardiovascular, gynecology, urology, radiology and orthopedic devices
Active devices
Software-driven devices
Implantable devices
Imaging devices
Aesthetic devices
And more

Regulations & Standards:

Medical device regulations: FDA, EU-MDR (CE), Amar (Israel), Canadian MDR, ARGMD (Australia), PMDA (Japan), and more
Quality Management Systems: ISO 13485 (2016), FDA medical device Quality System Regulations (21 CFR Part 820), Medical Device Single Audit Program (MDSAP)
ISO 14971 (2019) – Risk Management
ICH-GCP: Good Clinical Practice
Country specific labeling requirements
Additional safety, usability and device-specific standards

Submissions:

Pre-IDE, IDE, HUD, 510(k), PMA, de-novo
EU-MDR product submissions
Canada Medical Device License
Israeli Amar
ARTG (Australia) registration
PMDA/MHLW (Japan)
MFDS (S. Korea)
ANVISA (Brazil)
Change notices
And more

Compliance:

On-site quality system audits
Supplier audits
Training
CAPA management
Design control
Verification & validation
Change control
Complaints management
Post Market Surveillance (PMS)
Post Market Clinical Followup (PMCF)
Data analysis and management review
And more

What We Do

KeyMedic provides consulting services to the medical device industry, specializing in regulatory, quality and compliance solutions.

To help you even more we collaborate with Parente Studio, a Design and Development company that can help bring your company and product to the highest professional level.

All Services

Strategic Regulatory Consulting

Strategic regulatory consulting, development of regulatory plan, clinical investigations, regulatory submissions and more.

Quality Management Systems

Establishment and implementation of Quality Management Systems, inspection preparation & readiness assessment and more.

Quality & Regulatory Complience

Design control, V&V, risk management, quality audits, post market surveillance, recall management and more.

Branding, Design & Development

Branding, Logo, Business Cards, Product & Packaging Design, Website, Conference Booths, Ads, Brochures, Labeling, Patient Leaflets, User Manuals and more.